Vanda Pharmaceuticals Reports Second Quarter 2025 Financial Results
Fanapt® Q2 2025 net product sales increased by 27% to $29.3 million compared to Q2 2024
Bysanti™ (milsaperidone) NDA for bipolar I disorder and schizophrenia accepted for filing; PDUFA target action date of February 21, 2026
Tradipitant NDA for motion sickness accepted for filing; PDUFA target action date of December 30, 2025
Imsidolimab BLA in generalized pustular psoriasis expected to be submitted in 2025
WASHINGTON, July 31, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the second quarter ended June 30, 2025.
"We have witnessed accelerated growth of Fanapt revenue coinciding with the expansion of our sales efforts alongside a broad direct to consumer brand awareness campaign and we expect this trend to continue in the coming quarters," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "Significant regulatory and clinical milestones are expected in the coming months which have the potential to strengthen our commercial portfolio and advance our deep clinical pipeline."
Financial Highlights
Second Quarter of 2025
Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $52.6 million in the second quarter of 2025, a 4% increase compared to $50.5 million in the second quarter of 2024.
Fanapt® net product sales were $29.3 million in the second quarter of 2025, a 27% increase compared to $23.2 million in the second quarter of 2024.
HETLIOZ® net product sales were $16.2 million in the second quarter of 2025, a 13% decrease compared to $18.7 million in the second quarter of 2024.
PONVORY® net product sales were $7.1 million in the second quarter of 2025, an 18% decrease compared to $8.6 million in the second quarter of 2024.
Net loss was $27.2 million in the second quarter of 2025 compared to net loss of $4.5 million in the second quarter of 2024.
Cash, cash equivalents and marketable securities (Cash) was $325.6 million as of June 30, 2025, representing a decrease to Cash of $15.4 million compared to March 31, 2025.
First Six Months of 2025
Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $102.6 million in the first six months of 2025, a 5% increase compared to $97.9 million in the first six months of 2024.
Fanapt® net product sales were $52.8 million in the first six months of 2025, a 21% increase compared to $43.7 million in the first six months of 2024.
HETLIOZ® net product sales were $37.1 million in the first six months of 2025, a 4% decrease compared to $38.8 million in the first six months of 2024.
PONVORY® net product sales were $12.7 million in the first six months of 2025, an 18% decrease compared to $15.4 million in the first six months of 2024.
Net loss was $56.7 million in the first six months of 2025 compared to net loss of $8.7 million in the first six months of 2024.
Cash was $325.6 million as of June 30, 2025, representing a decrease to Cash of $49.1 million compared to December 31, 2024.
Key Operational Highlights, Commercial
Fanapt® experienced significant growth with total prescriptions (TRx)1 increasing by approximately 24% and Fanapt® net product sales increasing by 27% in the second quarter of 2025 as compared to the second quarter of 2024.
A direct to consumer campaign that started in the first quarter of 2025 continued in the second quarter of 2025, elevating brand awareness of the company and the key products Fanapt® and PONVORY®.
Key Operational Highlights, Regulatory & Clinical Development
Bysanti™ New Drug Application (NDA) for bipolar I disorder and schizophrenia is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of February 21, 2026.
Tradipitant NDA for motion sickness is under review by the FDA with a PDUFA target action date of December 30, 2025.
A Bysanti™ Phase III clinical study for use as a once-daily adjunctive treatment for major depressive disorder (MDD) is enrolling patients and results are expected in 2026.
Imsidolimab Biologics License Application (BLA) in generalized pustular psoriasis (GPP) expected to be submitted to the FDA in 2025.
GAAP Financial Results
Net loss was $27.2 million in the second quarter of 2025 compared to net loss of $4.5 million in the second quarter of 2024. Diluted net loss per share was $0.46 in the second quarter of 2025 compared to diluted net loss per share of $0.08 in the second quarter of 2024.
Net loss was $56.7 million in the first six months of 2025 compared to net loss of $8.7 million in the first six months of 2024. Diluted net loss per share was $0.96 in the first six months of 2025 compared to diluted net loss per share of $0.15 in the first six months of 2024.
2025 Financial Guidance
Vanda is reiterating its 2025 financial guidance and expects to achieve the following financial objectives in 2025:
Full Year 2025
Financial Objectives
Full Year 2025
Guidance
Total revenues
$210 to $250 million
Year-end 2025 Cash
$280 to $320 million
HHS Request for Information and Vanda Response
On May 14, 2025, the U.S. Department of Health and Human Services (HHS) issued a Request for Information (RFI) entitled "Ensuring Lawful Regulation and Unleashing Innovation To Make American Healthy Again." On July 14, 2025, Vanda submitted a public response to the RFI. Vanda's response proposed (1) that FDA repeal unlawful regulations that delay and overburden the drug approval process, and (2) that FDA repeal its 1990s-era guidance mandating lethal animal testing. The original RFI is available on the Federal Register website, under document number 2025-08384. Our full response with exhibits is available under the documents section of the Vanda website and on regulations.gov, under comment ID AHRQ-2025-0001-0962.
Conference Call
Vanda has scheduled a conference call for today, Thursday, July 31, 2025, at 8:00 AM ET. During the call, Vanda's management will discuss the second quarter 2025 financial results and other corporate activities. Investors can call 1-800-715-9871 (domestic) or 1-646-307-1963 (international) and use passcode number 9430387. A replay of the call will be available on Thursday, July 31, 2025, beginning at 11:00 AM ET and will be accessible until Thursday, August 7, 2025 at 11:59 PM ET. The replay call-in number is 1-800-770-2030 for domestic callers and 1-609-800-9909 for international callers. The ...